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Not Invasive Monitoring of Pleural Drainage

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Body Bioimpedance Sensor
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pleural Effusion focused on measuring pleural effusion, pleural drainage, thorax impedance, respiration parameters, heart sounds analysis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with pleural effusion undergoing pleural drainage
  • male and female patients aged at least 18 years

Exclusion Criteria:

  • pregnancy or breast feeding
  • implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol".
  • patients not being able to consent

Sites / Locations

  • Univeristy Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

non invasive sensor pleural drainage

non invasive sensor healthy control

Arm Description

feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor in Ohm before and after pleura drainage, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume before and after pleura drainage. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

the same measurements as in arm 1: feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor before and after pleura drainage in Ohm, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume once in 25 healthy controls. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Outcomes

Primary Outcome Measures

Change of thorax impedance (Ohm)
non invasive bioimpedance measurements to determine feasibility of body fluid loss before and after pleura drainage in 25 patients > 18 years old; also 25 healthy controls are measured to receive standard values

Secondary Outcome Measures

Change of Cardiac output ( l/min) via impedance cardiography
non invasive bioimpedance measurements to determine feasibility of impedance cardiography before and after pleura drainage; also 25 healthy controls are measured to receive standard values

Full Information

First Posted
January 25, 2013
Last Updated
April 15, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01778270
Brief Title
Not Invasive Monitoring of Pleural Drainage
Official Title
Not Invasive Monitoring of Pleural Drainage
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates if data about monitoring the drainage of pleural effusion can be collected by non invasive sensors (feasibility).
Detailed Description
25 patients > 18 years old with pleura effusion will be examined with regard to the feasibility of non invasive sensor measurements corresponding to the course of thorax impedance and respiration parameters during body fluids loss before and after pleural drainage. The measured data will be compared to standard routine reference measurements (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally heart sound analysis via electronic stethoscope will be compared to standard methods. Also 25 healthy controls will undergo the same measurements to receive standard values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
pleural effusion, pleural drainage, thorax impedance, respiration parameters, heart sounds analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non invasive sensor pleural drainage
Arm Type
Other
Arm Description
feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor in Ohm before and after pleura drainage, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume before and after pleura drainage. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.
Arm Title
non invasive sensor healthy control
Arm Type
Other
Arm Description
the same measurements as in arm 1: feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor before and after pleura drainage in Ohm, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume once in 25 healthy controls. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.
Intervention Type
Device
Intervention Name(s)
Body Bioimpedance Sensor
Primary Outcome Measure Information:
Title
Change of thorax impedance (Ohm)
Description
non invasive bioimpedance measurements to determine feasibility of body fluid loss before and after pleura drainage in 25 patients > 18 years old; also 25 healthy controls are measured to receive standard values
Time Frame
once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour.
Secondary Outcome Measure Information:
Title
Change of Cardiac output ( l/min) via impedance cardiography
Description
non invasive bioimpedance measurements to determine feasibility of impedance cardiography before and after pleura drainage; also 25 healthy controls are measured to receive standard values
Time Frame
once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour
Other Pre-specified Outcome Measures:
Title
Change of respiratory parameter CO2 in %/ml exhaled air
Description
respiratory parameters as CO2 in %/ml exhaled volume will be determined via capnograph
Time Frame
once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with pleural effusion undergoing pleural drainage male and female patients aged at least 18 years Exclusion Criteria: pregnancy or breast feeding implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol". patients not being able to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaus Marx, MD
Organizational Affiliation
Medical Clinic I, University Hospital Aachen
Official's Role
Study Director
Facility Information:
Facility Name
Univeristy Hospital Aachen
City
Aachen
State/Province
North Rhine Westfalia
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25861647
Citation
Zink MD, Weyer S, Pauly K, Napp A, Dreher M, Leonhardt S, Marx N, Schauerte P, Mischke K. Feasibility of bioelectrical impedance spectroscopy measurement before and after thoracentesis. Biomed Res Int. 2015;2015:810797. doi: 10.1155/2015/810797. Epub 2015 Mar 11.
Results Reference
derived

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Not Invasive Monitoring of Pleural Drainage

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